NCT04697225

Brief Summary

The objective of this study is to design, implement, and pilot a lifestyle-based, 12-week, weight loss program for parents of children with a disability. This weight loss program supports weight loss among parents. It is a first step towards a parent-only approach to promote healthier weight among children with a disability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

December 22, 2020

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight change among the parents at week 12

    Examine weight change (12 week - baseline) in kilograms (kg) among the parents in the 12-week weight loss program.

    baseline and 12 weeks

Secondary Outcomes (3)

  • Adherence with the scheduled weekly coaching calls

    baseline to 12 weeks

  • Weight change among the parents at week 24

    baseline and 24 weeks

  • Change in BMI z-score among the children

    baseline, 12, and 24 weeks

Study Arms (1)

weight loss program

EXPERIMENTAL
Behavioral: weight loss strategiesBehavioral: weight loss coaching sessions and email support

Interventions

Participants will receive recommendations on how to increase physical activity, decrease caloric intake, monitor their weight, and track the related behaviors and progress.

weight loss program

Participants will receive weekly coaching sessions and tailored support emails.

weight loss program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent
  • age ≥18
  • English speaking
  • completion of screening and baseline data collection
  • BMI ≥ 25 and weight \< 300lbs (weight limit due to scale limitations)
  • willing to lose weight through physical activity, weight tracking and decreased caloric intake
  • willing to make changes at home to facilitate a healthy weight
  • willing to complete 12 weekly weight loss video coaching sessions (20 minutes/session)
  • willing to use Skype, FaceTime, Zoom, or WebEx for regular intervention contact
  • Internet/ cellular plan that is sufficient for weekly program video conferencing
  • willing to use the study scale with cellular technology to report weights at baseline, 12 weeks, and 24 weeks.
  • willing to use the study scale with cellular technology at least weekly during the study (12 weeks)
  • completion of screening and baseline data collection
  • Child
  • age 8-18
  • +2 more criteria

You may not qualify if:

  • parent or child: previously diagnosed eating disorder, or treatment for an eating disorder
  • parent: currently pregnant or plan to get pregnant in the next 6 months
  • parent: planned weight loss surgery or procedure in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Towson University

Towson, Maryland, 21252, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gerald Jerome, PhD

    Towson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

January 6, 2021

Study Start

January 4, 2021

Primary Completion

October 31, 2022

Study Completion

November 30, 2022

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations